DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 150-168 are pending upon entry of amendment filed on 10/30/23.
Claims 150-168 are under consideration in the instant application.
The current claim set filed on 10/30/23 comprises 2 independent claims and the invention relates a pharmaceutical composition comprises LAC-3 antibody set forth in SEQ ID NO:3 and 5, PD-1 antibody set forth in SEQ ID NO17 and 18 and/or PD-L1 antibody, buffer, stabilizer and surfactant.
3. Applicant’s IDS filed on 10/30/24 and 10/21/25 have been acknowledged.
The non-English foreign patent is considered to its English abstract. Applicant is required to submit English translation if further consideration is required.
4. The oath filed on 6/16/23 has been acknowledged. The oath contains non-initialed alterations in p.2, 4 and 5. Appropriate correction is required.
5. Applicant is advised to spell out LAC-3, PD-1 or PD-L1 at its first appearance and claim 153 is missing a period (.).
6. A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
7. Claims 150-164, 167 and 168 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 150-164 and 168-169 of copending Application No. 19/025,919.
Both applications recite a pharmaceutical composition comprising:
from about 1mg/ml to about 300mg/ml of an anti-LAG-3 antibody or antigen binding fragment thereof;
from about 5mM to about 50mM of a buffering agent;
from about 50mM to about 300mM of a stabilizing or bulking agent; and
from about 0.001% to about 1%(w/v) of a surfactant.
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
8. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
9. Claims 153, 161 and 162 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 153 is indefinite in the recitation of BMS-986016, IMP731(H5L7BW), MK-4280 (28G-10), REGN3767, GSK2831781, BAP050, IMP-701(LAG-5250) or FS-118, claims 161 recites, MK-3475, CT-011, BMS-936558, RG7446, MEDI4736 or BMS-936559 and claim 162 is indefinite in the recitation of REGN2810, LAG525, or PDR001 respectively. Although some designations are exclusive for pharmaceutical companies and characteristics are known, IMP731(H5L7BW) or MK-4280(28G-10), FS-118 or CT-011 are deemed laboratory designations.
The use of IMP731(H5L7BW) or MK-4280(28G-10), FS-118, CT-011 or PDR001 antibody as sole means of identifying claimed antibody renders the claims indefinite because the IMP731(H5L7BW) or MK-4280(28G-10), FS-118, CT-011 or PDR 001 is a merely a laboratory designation which does not clearly define the claimed product, since different laboratories may use the same laboratory designations to define distinct antibodies.
Claim 161 contains the trademark/trade name KEYTRUDA, OPDIVO, TECENTRIQ or IMFINZI. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe pembrolizumab, nivolumab, or atezolizumab and, accordingly, the identification/description is indefinite. In addition, claim 161 recites multiple limitations in the parenthesis. It is not clear whether the limitations in the parenthesis are required or which limitation is required.
10. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
11. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
12. Claim(s) 167-168 is/are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by U.S. Pub. 2006/0088523.
The ‘523 publication teaches antibody formulations comprising a monoclonal antibody, 10-40mM of histidine buffer, 250mM of stabilizer (e.g. sucrose) and 0.01-0.1% surfactant (note claims 1-10). Therefore, the reference teachings anticipate the claimed invention.
13. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
14. Claims 150-168 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO2015/042246 (IDS reference) in view of U.S. Pat. 9,220,776 (IDS reference) and U.S.Pub.2005/0276823 (IDS reference).
The ‘246 publication teaches administration of LAG-3 and PD-1 antibody in intravenously (p. 7) at 80 mg and 240 mg, respectively. This meets the limitation of ratio of LAG-3 and PD-1 about 1:4 of claim 163. Further, the kits comprising a pharmaceutical composition comprising LAG-3 and PD-1 (p.8, 17) with pharmaceutically acceptable excipients are taught. The antibody includes claimed SEQ ID NO:3, 5, 19 and 21 where BMS986010 and BMS-936558 comprise the claimed SEQ ID NO:1-3, 5, 9 and 21, respectively. Further it is evidenced to comprises the CDR’s set forth in CDRs in SEQ ID NO: 1-12, 23-28, respectively as in claims 153 and 161 of the instant application.
Further, the 246 publication teaches kits and dosage forms in pre-filled syringes as well as infusion bags required by the appropriate vehicles and administration methods (p. 17).
The disclosure of the ‘246 publication differs from the instant claimed invention in that it does not teach the use 5-50mM of buffer (note examples in claim 154, e.g. histidine), 50-300mM of stabilizer (note examples 154, e.g. sucrose), 0.001-1% of surfactant, 5uM to 1mM of chelating agent or DTPA, and pH of 5-6 as in claims 150, 154-158 of the instant application.
The ‘776 patent teaches formulation of PD-1 antibody in the presence of 10-20mM histidine buffer, 70mg/ml of sucrose (7%, with the molecular weight of 342, equivalent of 205mM), 0.02-0.05% polysorbate with USP water at pH about 5.5 (col. 19-20, claims 1-6). The pH about 5.5 reads on the claimed about 5.8. The ‘776 patent allows addition of 0.9% sodium chloride and sterile dextrose for infusion (col. 19). The PD-1 antibody is stabilized in the formulation comprising histidine, sucrose, polysorbate and/or NaCl or dextrose in lyophilized formulation (col. 10-25). The antibody composition improves stability by reduction of aggregation (col 15).
The ‘823 publication teaches addition of DTPA from 1uM-10mM in the presence of histidine from 10uM-200mM with isotonic agent including sucrose upto 25% ([0059-0073]). The addition of DTPA improve stability by reduction of oxidative degradation as DTPA acts as metal chelators/
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize histidine, DTPA, sucrose and polysorbate as taught by the ‘776 patent and ‘823 publication into the LAG-3 and PD-1 antibody formulation taught by the ‘246 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the formulation of PD-1 and LAG-3 antibody in the histidine, sucrose, polysorbate and DTPA of known concentration would stabilize and improve shelf life by reduction of aggregation caused by the oxidative degradation of antibody. The composition that is suitable for PD-1 antibody of the ‘776 patent would be suitable for PD-1 and LAG-3 as the ‘246 publication discloses co-formulation of those two antibodies and the DTPA is suitable for any antibody (p. 2-5) where the addition of antioxidant is generally known for antibody formulation art.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
15. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321 (b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
16. Claims 150-168 are rejected on the ground of nonstatutory obviousness- type double patenting as being unpatentable over claims 1-24 of US Patent No: 11,723,975.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘975 patent recites a pharmaceutical composition LAG-3 antibody (and PD-1 or PD-L1 antibody) in the presence of histidine buffer, 250mM sucrose, 20uM of DPTA, about 0.05% polysorbate at pH5-6 wherein the LAG-3 antibody has SEQ ID NO:1-2, 3 and 5, PD-1 antibody set forth in SEQ ID NO:17-19 and 21.
17. No claims are allowable.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
January 6, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641